There is a mountain of proof that shows that you will achieve the desired hard clinical and financial outcomes with our recommended systems and protocols. The first and most important evidence comes from controlled clinical trials.
Controlled Clinical Trials
There are controlled clinical trials that underpin everything that I have said to this point. Heart disease is still the leading cause of death for American men and women. One of our major priorities should be reducing the premature disability, deaths, and costs related to heart disease. There is hard proof that we can do that in an organization like yours.
There are around 15 clinical trials that prove optimal medical therapy alone is as good as OMT plus a stent in patients with stable coronary artery disease in preventing heart attack or sudden death. Opening arteries in patients with stable angina provides no additional benefit over OMT alone. In unstable patients with acute coronary syndromes, opening the artery saves heart muscle and lives. Opening arteries is essential in that case and that is the appropriate use.
There is another study that compares optimal medical therapy (OMT) for patients with coronary artery disease with usual care—The care that most of us receive. That is the most important clinical trial in all of cardiology. This controlled clinical trial came out of the cardiac rehabilitation service within the Kaiser Permanente health system in Colorado. The trial compared optimal medical therapy vs. usual care in patients who had had a heart attack. Patients in the optimal medical therapy group received care from a team of pharmacists and nurses empowered to make changes in real time based on a best practice evidence-based protocol without checking with the doctor. It made a huge difference in intermediate outcomes. 91% of patients in the OMT group took a statin vs about half that many nationally in usual care.
Patients on OMT were ten times more likely to be alive in five years compared with the patients in usual care. The same magnitude of benefit was seen in all-cause mortality when compared with cardiovascular mortality. Providing care for patients on OMT was thousands of dollars less expensive per patient per year. You can replicate what the nurse pharmacist teams did. It happened in a real clinical practice. You can see the details here. There is no other treatment for coronary artery disease that comes anywhere close to that level of benefit. How can we defend the fact that most patients in this country do not have access to OMT after a heart attack now. It must be a national priority to develop these advanced primary care teams that consistently deliver OMT now.
There is an equally impressive controlled clinical trial involving people who have type 2 diabetes and chronic kidney disease diagnosed because they have microalbuminuria— small amounts of protein in their urine. These patients typically have relentlessly progressive deterioration of kidney function. Most of them don’t live long enough to go on dialysis because they die of heart attacks and strokes. They are a very high-risk group. You see ads for Ozempic touting a 26% reduction in heart attack risk. OMT is an order of magnitude more effective than Ozempic. Patients with type 2 diabetes and chronic kidney disease on OMT had one fourth as many heart attacks, one fifth as many strokes, and one sixth as many people progressed to dialysis when compared with patients on usual care. Over 21 years of follow-up, patients on OMT lived 8 years longer and their heart attack and strokes we delayed by 8 years compared with patients receiving usual care. They were healthier and more fully functional longer. Patients on OMT were 70% less likely to be admitted to the hospital for congestive heart failure.
In both the coronary artery disease and the type 2 diabetes study, most care was delivered by nurses and or pharmacists using a protocol under physician supervision in circumstances very much like community practice. Both trials did a better job of making standards of care standard. They achieved lower risk factors levels using interventions that have a greater impact on clinical and financial outcomes than achieving the same risk factor level using another method. Both trials dramatically impacted hard outcomes, and their methodology can be replicated in the community. That means their results can be replicated in the community.
Personal Experience
I have personal experience doing this kind of work and produced dramatically lower risk factor levels in high-risk older patients compared with my peers. The improvement was due to a focused systematic approach using a protocol very similar to the one in the clinical trails. I led a team of three pharmacists with ambulatory care residency training who moved the blood pressure, blood sugar, and cholesterol numbers just as well as the team in Colorado. We did not have access to event rates like heart attack of death, but we definitely improved intermediate outcomes like blood pressure control rates.
That led to work with BCBS of Louisiana. It was a voluntary program and the best performers were small independent primary care practices. In this Quality Blue Primary Care Initiative, we targeted patients with hypertension, diabetes, chronic kidney disease, and ischemic vascular disease. Within a year we were saving $27 per member per month by reducing the number of hospitalizations, lengths of hospital stay, and specialty referrals. We promoted optimal medical therapy protocols in regional collaborative presentations and in meetings at the home office with physician leaders from across the state.
Since then, I worked with a worksite clinic in Southwest Louisiana that cares for casino employees and members of a Native American tribe. It is manned by one family practitioner and 4 nurse practitioners who are all trained on OMT and use a protocol. Patients who are engaged with the clinic, compared with patients seen in the broader community cost half as much, they are hospitalized one fifth as often, and they are in the ER one third as often. We are also working with employees of a large medical provider who have high risk cardiometabolic conditions, and we are saving about $5000 dollars a year for each engaged employee.
The Proof Is In
There is no more need for pilots to prove OMT is dramatically superior to the care that most of us receive for chronic diseases in usual care. That work has been done. The clinical trials I have cited compared the care in thousands of patients. Kaiser Permanente has translated team-based OMT into their general clinical operations. They now have 12,000 patients in their Collaborative Coronary Care Service in Colorado. They applied a similar process to hypertension control in Northern California. Nationally, patients with a diagnosis of high blood pressure have their blood pressure controlled to less than 140/90 only 44% of the time. In Northern California, advanced primary care teams doubled that number to a 90% control rate in 750,000 patients. This is much more effective blood pressure control, and it is better treatment for vascular disease. That effort in Northern California has delayed thousands of strokes and heart attacks while slowing the progress to chronic kidney disease. That is proof that we can do a much better job with patients who have had a heart attack or who have hypertension.
Now there is a randomized clinical trial published in JAMA Cardiology on controlling high blood pressure in rural China entitled “Multifaceted Blood Pressure Control Model in Younger and Older Individuals with Hypertension.” This effort was led by community healthcare workers who were not physicians. This trial included nearly 34,000 patients. This one intervention reduced cardiovascular events by 25% and all-cause mortality by 10% in patients older than 60 over a 4 year period. The risk of heart failure in patients younger than 60 was reduced by 61%. The community health workers used a simple stepped care protocol to manage high blood pressure to a target of 130/80. Home blood pressures were measured using an automatic blood pressure device Omron HBP-1100U. The difference in systolic blood pressure (top number) between the usual care group and the intensively managed group was 21 points. (149 vs 128). There was a ten point difference between the diastolic pressures (bottom number 84 vs 74). This simple protocol-driven program produced a huge difference in blood pressure control and in the outcomes that really matter—cardiovascular events and mortality.
Other organizations using these advanced primary care teams in the United States are already providing excellent care at half the cost of usual care in their era. One example is the SouthCentral Foundation which is owned by Native Alaskan. Another is Vestra Health.
The nation that has done the best job of developing advanced primary care teams that treat chronic conditions more effectively is Singapore. They are known for adopting best practices in all institutions including health care. They are a nation of five million people, and all citizens have health care coverage. They have 20 one-stop primary care clinics scattered around their country and those clinics contain HDL teams where the care is delivered by pharmacists. HDL stands for hypertension, diabetes, and lipids. Those teams focus on those conditions, and they do a great job. These advanced primary care teams are part of the reason that Singapore spends 5% of gross domestic product on healthcare and we spend 20%--and they live longer! That is just one more element of proof that better chronic disease management improves and saves money.
This evidence of reductions of hard clinical events is so compelling that the Steno 2 investigators stopped the usual care arm of the study eight years into the trial. Since the difference in diabetes complications was so great, they decided it would be unethical to continue usual care—the care that most of us receive. The leading cardiologists who led the landmark trials proving OMT alone is as good as OMT plus a stent, concluded “OMT should be a universal standard of Care” and now entire countries like Great Britain have adopted that approach in coronary artery disease. How can we defend the fact that OMT is not available to every person in the United States who has cardiovascular disease or a related condition like high blood pressure or diabetes? I can’t defend it.